Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD) (DISCO)
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Purpose
Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Behavioral: 5 portions fruit and vegetables/day Behavioral: <= 2 portions fruit and vegetables/day |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) |
- Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 81 |
| Study Start Date: | February 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
<= 2 portions fruit and vegetables/day'
|
Behavioral: <= 2 portions fruit and vegetables/day
Participants continue to consume usual diet containing <= 2 portions fruit and veg per day
|
|
Experimental: 2
5 portions fruit and vegetables/day
|
Behavioral: 5 portions fruit and vegetables/day
Participants consume > = 5 portions fruit and veg per day
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- moderate to severe COPD (according to GOLD classification)
- oxygen saturation >= 92 KPa
- symptomatically stable
- habitually low fruit and vegetable intakes (<=2 portions daily)
- exercise limited by shortness of breath (rather than e.g. angina, arthritis)
Exclusion Criteria:
- diabetes
- taking antioxidant supplements or drugs
- oxygen saturation <8KPa
Contacts and Locations| United Kingdom | |
| Queen's University Belfast | |
| Belfast, Co.Antrim, United Kingdom, BT12 6BJ | |
| Principal Investigator: | Ian Young, MD | Queen's University, Belfast |
More Information
No publications provided by Queen's University, Belfast
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr M McKinley, Lecturer |
| ClinicalTrials.gov Identifier: | NCT00435708 History of Changes |
| Other Study ID Numbers: | Ref 200651 |
| Study First Received: | February 14, 2007 |
| Last Updated: | November 6, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Queen's University, Belfast:
|
COPD Fruit Vegetables Oxidative stress Inflammation |
Additional relevant MeSH terms:
|
Inflammation Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013